ISO 9001:2015 Calibration Procedures

DavidJ.BlackII

Starting to get Involved
ASME and ASTM procedures are considered to be "internationally recognized' documents. Procedures from the OEM, GIDEP military procedures, NIST handbooks, etc. are also well accepted by auditors. A caveat is that most auditors will check to see if you perform the procedure as written, using all steps and the equipment called for.
When you write your own procedures you will need to validate them as being effective, and adequate for the equipment you are using them for.
Wow that's weird. So, gages used to calibrate and operate need standards to be compared to, and those standards need to be traced to more accurate standards and so on. But for a process standard you just need to be able to reproduce the steps each time and dictate that you can accurately measure the variation in a gage's ability to measure?
 

Enghabashy

Quite Involved in Discussions
The Q. Is : How do I confirm that a standard such as ASME is valid in my scope?
The Answer: The test procedure shall reflect all referenced STDs. used ; All STDs. should comply with follow up record in your system to online checking the last version , the auditor can refer to the documented record to check that you follow the last issues
 

dwperron

Trusted Information Resource
Wow that's weird. So, gages used to calibrate and operate need standards to be compared to, and those standards need to be traced to more accurate standards and so on. But for a process standard you just need to be able to reproduce the steps each time and dictate that you can accurately measure the variation in a gage's ability to measure?

Exactly. With your validated procedure you will have a method that will produce acceptable results, and you will be able to duplicate those results. By maintaining measurement traceability to a national laboratory you are ensuring the accuracy of those results.
 

DavidJ.BlackII

Starting to get Involved
The Q. Is : How do I confirm that a standard such as ASME is valid in my scope?
The Answer: The test procedure shall reflect all referenced STDs. used ; All STDs. should comply with follow up record in your system to online checking the last version , the auditor can refer to the documented record to check that you follow the last issues

Would I have to implement it somehow or are internationally recognized standards like ice cream; I can just pick and choose what flavors I want? I guess what I’m asking is, even though my company calls out VDI VDE 2618 as our standards used for calibrations, what’s stopping me from calibrating all of our gages with different process standards? We are an in-house calibration lab for an automotive company, and I deal with a lot of “linear measurement” equipment, as well as male & female thread ring gages, male & female spline gages, diameter gages, simple & compound sine plates (angular measurement), dial bore gages, chamfer gages, measuring wires, gauge blocks (I’m up to my ears in gage blocks, depth blocks, multiple inch and metric sets of gauge blocks, etc.); THERE ARE OVER 3,000 GAGES TOTAL!!! Well, more like 1,700 active gages, the rest are deactivated waiting to be used or broken, and we keep records even on broken gages we no longer use.
 

Enghabashy

Quite Involved in Discussions
Would I have to implement it somehow or are internationally recognized standards like ice cream; I can just pick and choose what flavors I want? I guess what I’m asking is, even though my company calls out VDI VDE 2618 as our standards used for calibrations, what’s stopping me from calibrating all of our gages with different process standards? We are an in-house calibration lab for an automotive company, and I deal with a lot of “linear measurement” equipment, as well as male & female thread ring gages, male & female spline gages, diameter gages, simple & compound sine plates (angular measurement), dial bore gages, chamfer gages, measuring wires, gauge blocks (I’m up to my ears in gage blocks, depth blocks, multiple inch and metric sets of gauge blocks, etc.); THERE ARE OVER 3,000 GAGES TOTAL!!! Well, more like 1,700 active gages, the rest are deactivated waiting to be used or broken, and we keep records even on broken gages we no longer use.
Dear Sir
The calibration certificates shall reflect the results with essential parameters like class /accuracy , uncertainty --etc.
According your checking of all results ‘ you have to decide the time needed to re-calibrate each device , many factors should be considered when you schedule the times for re-calibration of each device/instrument , the in-house calibration or setting " if applicable "; the inter-lab. comparison / how many you are using the device/ gauge “in service/work day---etc.“--, the intermediate check & PT requirements, therefore the calibration plan / schedule should be initiated with all cross referenced of this factors 'including intermediate checks & and above considerations , --- finally there's no requirements relating re-calibration period , it's not the decision of the external lab., but maybe if the external lab. found the results are approaching critical values ' the lab may state a recommendation accordingly
 

dwperron

Trusted Information Resource
Does your company call out VDI VDE 2618 as the calibration standard, or is it listed as one of multiple possibilities? If it is the sole standard then you really don't have a choice but to comply with it. You might be able to generate internal procedures or adopt external ones, but be prepared to defend that your procedures produce equivalent results, with documentation of your work. In most cases the effort involved isn't worth it, so you just use the procedures that are called for.
Just for comparison, I work for an AS9100D certified aerospace contractor. We have 5 labs supporting 78,000 active instruments in our database (56,000 on calibration recall) and have a library of over 225 procedures, many of which are for generic categories such as torque tools, scales, pressure gauges, etc.
 

Pramod shirsath

Qa engineer
Almost all industries used monitoring and measuring equipment to manufacture products or support services, it is required that this equipment must be calibrated in order to ensure that the intended product specification is achieved. In short, quality is maintained when calibration is performed.

ISO 9001 is the quality management system designed for manufacturers (producers of products) or service providers. There are other more specific standards for specialized industries like automotive, pharmaceuticals or Oil and Gas but ISO 9001 is still integrated with them.

For a calibration process to be properly implemented, there should be in-house calibration management that we should follow.

What is calibration and why do we need calibration? Visit my other post in this link >> calibration awareness

This calibration management is guided by ISO 9001: 2015 Standards which has dedicated clauses that detail the requirements needed for proper implementation.

In this article, I will share with you:

1. The related clauses of ISO 9001 that are focused mainly on calibration requirements.
 
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